Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

South Orange County Medical Research Center, Laguna Woods, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of adenocarcinoma of the prostate
Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
Detectable metastases
ECOG performance status of 0 or 1

Exclusion criteria

Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
Significant cancer related pain
Prior gene therapy, chemotherapy, or immunotherapy

Treatment and study plan

Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Biological

Sponsors and collaborators

Lead sponsor

Cell Genesys

Industry

Registry information

Official study title

A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

Important dates

Study start: 2001
Study completion: 2005
First posted: Sep 1, 2005
Registry last updated: Dec 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed